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MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202
Vicks Childrens Vaporub Ointment
FDA Label NDC 58933-595
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Procter & Gamble Manufactura S De Rl De Cv for the product Vicks Childrens Vaporub (NDC 58933-595). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, do not, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Camphor (synthetic) 4.8%
Eucalyptus oil 1.2%
Menthol 2.6%
Otc - Purpose
Cough suppressant & topical analgesic
Cough suppressant
Cough suppressant & topical analgesic
Uses
- when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
- when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints
Warnings
For external use only; avoid contact with eyes.
Do Not Use
- by mouth
- in nostrils
- on wounds or damaged skin
- with tight bandages
Ask A Doctor Before Use If You Have
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
When Using This Product, Do Not
- heat
- microwave
- add to hot water or any container where heating water.
May cause splattering and result in burns.
Stop Use And Ask A Doctor If
- muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days.
- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• see important warnings under "When using this product"
• adults and children 2 years and over:
- • for cough suppression
- • rub a thick layer on throat & chest
- • cover with a warm, dry cloth if desired
- • keep clothing loose about throat and chest to help vapors reach the nose and mouth
• use up to three times daily or as directed by doctor
• for muscle / joint minor aches and pains apply to affected area not more than 3 to 4 times daily
• children under 2 years: do not use
Other Information
- store at room temperature
Inactive Ingredients
cedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil
Questions?
1-800-873-8276
Principal Display Panel - 50 G Jar Carton
VICKS ®
children's
VapoRub™
COUGH SUPPRESSANT
TOPICAL ANALGESIC
Ointment
2+ years
NET WT 1.76 OZ (50 g)
595 (595)
* Please review the disclaimer below.
